Methyl valerate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from August 2002 to February 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

- 3 (females) and 9 (males) instead of 5 animals/sex used

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl valerate

EC Number:

210-838-0

EC Name:

Methyl valerate

Cas Number:

624-24-8

Molecular formula:

C6H12O2

IUPAC Name:

methyl pentanoate

Test material form:

liquid

Specific details on test material used for the study:

- Solubility and stability of the test substance in the solvent/vehicle: The liquid original compound was used

Test animals

Species:

rat

Strain:

other: Shoe: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwald GmbH, schönwald, germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 263-328 g (males); 181-188 g (females)
- Housing: conventional; 1 animal per cage
- Diet (ad libitum): pell. Ssniff R/M
- Water (ad libitum): demineralized, acidified, pH 2-3
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 54-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

step I (3 males 2000 mg/kg (nominal)) had to be repeated because the application volume was to low.
step II (3 males 2000 mg/kg) had to be repeated because inadvertently the application areas were not observed 48 and 72 after termination of treatment.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (females)
9 (males)

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: no clinical signs

Gross pathology:

No findings

Any other information on results incl. tables

The slight decrease in body weight in one male animal on day 7 was not considered to be compound related because it was noted in one male animal only.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.